DesignThis is a prospective, randomized double-armed (controlled) clinical trial.
Participants:Thirty ischemic heart patients who were already scheduled for first-time isolated CABG with either nonviable or ungraftable myocardial segments, which was not suitable for conventional forms of revascularization. There were 27 males and 3 females (their ages ranged between 44 to 74 years old with a mean of 58.77).
AbstractBackground: To assess the usefulness of intra-myocardial autologous stem cell injection as a hybrid procedure with coronary artery bypass grafting (CABG) compared to conventional CABG only in the patients with ischemic heart disease with non-viable or non-graftable myocardial segments.Methods: After approval of Local Ethics Committee and obtaining written informed consent, a prospective, comparative randomized study was conducted on 30 ischemic heart patients with non-viable or non-graftable segments. They were divided into two groups. Group A (15 patients): where intra myocardial injection of autologous bone marrow mononuclear cells (ABM-MNCs) was done in conjunction with CABG. Group B (15 patients): where CABG was performed only. Resting and stress echocardiography follow up was done for 6 months.Results: There was no mortality in either group. No complications were noted at a mean of 6 months after surgery. Group A showed a significant improvement (mean of 7.25% and P<0.001) in left ventricular ejection fraction (LVEF). Both end-diastolic (LVEDD) and end-systolic (LVESD) diameters showed significant decrease compared to pre-operative values. LVEDD decreased by a mean of 5.23 (P <0.001) while LVESD by a mean of4.21 (P<0.001).
Conclusion:Stem cell therapy combined with CABG improves cardiac function compared with revascularization alone. In the same time, it is safe, feasible, and reproducible and doesn't increase the risk of major adverse events or mortality.